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This device is designed to produce cross-sectional images of a human body by reconstruction of xray transmission data from the same axial plane taken at different angles. These images have been ray transmoses in cally useful in the diagnosis of spine and head injuries, intracranial tumors, blood clots in the brain, eye trauma, soft tissue lesions in the extremities, gastrointestinal lesions, abdominal and pelyic malignancies, and hepatic metastases. CT is also used to evaluate intestinal obstructions, assess intra-abdominal abnormalities and to examine musculoskeletal degeneration. This device employs no intended uses that are not in cleared devices already found in the marketplace.

X-ray imaging of whole body - Computerized Tomography Including: Axial Volumetric (Helical) CT Fluoroscopy

The Aquilion 32/64 SP is a multi-slice helical CT system, consisting of a gantry, patient couch and console. The system generates up to 128 axial slices per second using a selectable slice-thickness multi-row detector.

The provided document is a 510(k) summary for the Toshiba Aquilion 32/64 SP CT systems (K051833). It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The 510(k) summary focuses on demonstrating that the new device has the same technological characteristics and intended uses as the predicate device (Aquilion MS-32/64 CT scanners [K033418]), thereby establishing substantial equivalence. This type of submission generally relies on demonstrating similarity to a legally marketed device rather than presenting detailed performance studies with acceptance criteria in the public summary.

Therefore, I cannot extract the requested information from the provided text. The document states:

• "This device employs the same technological characteristics as the predicate device, differing only in the specifics of subassembly component composition."
• "This device employs no intended uses that are not in cleared devices already found in the marketplace."
• "Based upon the above considerations TAMS believes that Aquilion SP-32/64 scanners are substantially equivalent to the predicate Aquilion MS-32/64 CT scanners [K033418]."

These statements indicate that the
regulatory pathway for this device relied on demonstrating equivalence to an existing device, rather than providing independent performance data against specific acceptance criteria in this document.

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